Diaphragm paralysis; surgery or mechanical ventilation?
- Conditions
- 20 participants >18 year and diagnosed with a unilateral of bilateral diaphragm paralysis resulting from phrenic nerve injury.
- Registration Number
- NL-OMON24116
- Lead Sponsor
- ZonMw
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
In order to be eligible to participate in this study, a participant must meet all of the following criteria:
•>18 years
•diagnosed with a unilateral or bilateral diaphragm paralysis based on isolated phrenic nerve injury.
oUnilateral or bilateral diaphragm paralysis is defined as follows: complaints of dyspnea and / or orthopnea combined with a drop in VC of more than 15% when change from upright to supine position and a positive sniff test during fluoroscopy or ultrasonography. A positive sniff test means that the diaphragm stands still or even moves in cranial direction (paradoxical movement ) during the sniff inspiratory maneuver.
•Ability to provide written consent
•Time between diagnosis and treatment should be at least 1 year
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Patients diagnosed with a unilateral or bilateral diaphragm paralysis due to a more systemic neurological or neuromuscular disorder like for example Amyotrophic Lateral Sclerosis ,
•Hypercapnia during daytime (PaCO2 > 6.0 kPa)
•Radiotherapy of the thorax
•Contra indication for diaphragm surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method